(262 days)
Not Found
No
The device description and performance studies focus on the chemical composition, physical properties, and biocompatibility of a personal lubricant, with no mention of AI or ML.
No.
The intended use of the device is to moisturize and lubricate to enhance comfort during intimate sexual activity, which is not a therapeutic purpose.
No
Explanation: The device is a personal lubricant intended to moisturize and lubricate for enhancing intimate sexual activity. It does not perform any diagnostic function.
No
The device is a personal lubricant, which is a physical substance, not software. The description details its chemical composition, packaging, and physical properties.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a personal lubricant for penile and/or vaginal application to enhance sexual activity and supplement natural lubrication. This is a topical application for physical comfort and function, not for diagnosing a condition or analyzing a sample from the body.
- Device Description: The description details the physical properties and composition of a lubricant. There is no mention of reagents, assays, or any components designed to interact with biological samples for diagnostic purposes.
- Performance Studies: The performance studies focus on biocompatibility, condom compatibility, and shelf life – all relevant to a personal lubricant, but not to an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVD devices are designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
SuperSlyde lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms. This product is not compatible with polyurethane and polyisoprene condoms.
Product codes (comma separated list FDA assigned to the subject device)
NUC
Device Description
SuperSlyde is an anhydrous, non-sterile, clear, silicone-soluble liquid for use as a personal lubricant. It is made of dimethicone and dimethiconol.
The specifications for SuperSlyde include appearance, color, odor, viscosity, total aerobic microbial count per USP , total yeast and mold count per USP and absence of pathogenic organisms per USP . Osmolality, pH and antimicrobial effectiveness test parameters are not applicable because the subject lubricant is non-aqueous based formulation.
The product is packaged in a polyethylene terephthalate (PET) bottle with a screw-on, press-top polypropylene (PP) in volumes of 100ml, 250ml and 400ml.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile and/or vaginal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility: SuperSlyde Personal Lubricant has undergone biocompatibility testing including cytotoxicity, sensitization, vaginal irritation and acute systemic toxicity testing per ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-10:2010 and ISO 10993-11:2006, respectively. The testing found that SuperSlyde Personal Lubricant is biocompatible.
Condom Compatibility: The compatibility of the subject device with natural rubber latex, polyisoprene, and polyurethane condoms was evaluated in accordance with ASTM D7661-10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results of this test demonstrated that the subject device is compatible with natural rubber latex condoms. This product is not compatible with polyisoprene and polyurethane condoms.
Shelf Life Testing: The results of shelf life testing demonstrate that the subject device meets its specifications over the duration of its proposed shelf life.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 884.5300 Condom.
(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 19, 2018
ICM Pharma Pte Ltd Moturi Srinivasa Rao Regulatory Affairs Manager 26 Kallang Place #05-17 Singapore, 339157 Sg
Re: K172306
Trade/Device Name: SuperSlyde Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: March 15, 2018 Received: March 19, 2018
Dear Moturi Srinivasa Rao:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
1
(Sections 531-542 of the Act); 21 CFR 1000-1050.
You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joyce M. Whang -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| EPARTAL
Food and Drug Administration
ndications for Use | Form Approved: OMB No. 0810-0120
iration Date: 06/30/2020
PRA Statement below. |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| amoux yı) rəqunun (x)Obç | |
| SuperSlyde Personal I.ubrican
Device Name | |
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on the submit
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3
510(k) Summary
K172306
| K172306 | ICM PHARMA PTE LTD | |
|---|---|---|
| 26 Kallang Place #05-17 Singapore 339157 | ||
| Submitted by: | ICM Pharma Pte Ltd | Tel: (65) 6296 5411 Fax: (65) 6293 4967 |
| 26 Kallang Place #05-17 | E-mail: icmwi@icmpharma.com | |
| Singapore 339157 | Website: www.icmpharma.com.sg | |
| Contact Person: | Moturi Srinivasa Rao | |
| ICM Pharma Pte Ltd | ||
| 26 Kallang Place #05-17 | ||
| Singapore 339157 | ||
| Tel: 65-6296-5411 | ||
| Fax: 65-6293-4967 | ||
| email: srinivasa.moturi@icmpharma.com | Co. Regn No: 198601755R | |
| Date Prepared: | 08/03/2018 | |
| Proposed Trade | ||
| Name: | SuperSlyde Personal Lubricant | |
| Common Name: | Personal Lubricant | |
| Classification Name: | Condom | |
| 21 CFR884.5300 | ||
| Class II | ||
| NUC (lubricant, personal) | ||
| Predicate Device | Wet Platinum Premium Lubricant | |
| 510(k) No: K130012 | ||
| The predicate device has not been subject to a design related recall. | ||
| Device Description: | SuperSlyde is an anhydrous, non-sterile, clear, silicone-soluble liquid for use as a personal | |
| lubricant. It is made of dimethicone and dimethiconol. | ||
| The specifications for SuperSlyde include appearance, color, odor, viscosity, total aerobic | ||
| microbial count per USP , total yeast and mold count per USP and absence of | ||
| pathogenic organisms per USP . Osmolality, pH and antimicrobial effectiveness test | ||
| parameters are not applicable because the subject lubricant is non-aqueous based | ||
| formulation. | ||
| The product is packaged in a polyethylene terephthalate (PET) bottle with a screw-on, | ||
| press-top polypropylene (PP) in volumes of 100ml, 250ml and 400ml. | ||
| Indications for Use: | SuperSlyde lubricant is a personal lubricant, for penile and/or vaginal application, intended to | |
| moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and | ||
| supplement the body's natural lubrication. This product is compatible with natural rubber | ||
| latex condoms. This product is not compatible with polyurethane and polyisoprene condoms. | ||
| Technological | ||
| Characteristics: | SuperSlyde has similar ingredients to the predicate device. However, SuperSlyde and the | |
| predicate device have different technological characteristics, including their formulation and | ||
| specifications. The differences in technological characteristics do not raise different | ||
| questions of safety or effectiveness. | ||
| Summary of Performance Testing: | ||
| Biocompatibility: | SuperSlyde Personal Lubricant has undergone biocompatibility testing including cytotoxicity, | |
| sensitization, vaginal irritation and acute systemic toxicity testing per ISO 10993-5:2009, ISO | ||
| 10993-10:2010, ISO 10993-10:2010 and ISO 10993-11:2006, respectively. The testing found | ||
| that SuperSlyde Personal Lubricant is biocompatible. | ||
| Condom | ||
| Compatibility | The compatibility of the subject device with natural rubber latex, polyisoprene, and | |
| polyurethane condoms was evaluated in accordance with ASTM D7661-10 Standard Test | ||
| Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex | ||
| Condoms. The results of this test demonstrated that the subject device is compatible with | ||
| natural rubber latex condoms. This product is not compatible with polyisoprene and | ||
| polyurethane condoms. | ||
| Shelf Life Testing: | The results of shelf life testing demonstrate that the subject device meets its specifications | |
| over the duration of its proposed shelf life. | ||
| Conclusion: | The performance data demonstrate that the SuperSlyde Lubricant is substantially equivalent | |
| to its proposed predicate device. |